Refractory Partial Seizures
Conditions
Keywords
Seizure, Seizures, Epilepsy
Brief summary
This study will evaluate the efficacy and safety of Rufinamide in reducing seizure frequency in subjects with partial seizures not fully controlled despite treatment with 1 to 3 concomitant antiepileptic drugs.
Interventions
DRUGRufinamide
Rufinamide
Sponsors
University of South Alabama
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male and Female patients between 12 and 80 years of age * Dx of epilepsy with partial onset seizures woth or woth out secondarily generalized seizures * Non controlled partial seizures despite treatment with 2 different AEDs for at least 2 years * must have 6 seizures during baseline * current treatment with maximum of 3 AEDs * stable dose of AED(s)for at least 1 month * if patient has VNS, must have been implanted 6 months prior to randomization
Exclusion criteria
* Participation in any investigational product for at least 1 month prior to visit 1 * Presence of non-motor simple partial seizures only * presence of generalized epilepsies * Evidence of clinically significant disease * Clinically significant ECG * Psychogenic seizure in previous year * History of drug/alcohol abuse * History of suicide attempt * Multiple drug allergies * Concomitant felbamate use * Need for frequent rescue benzodiazepines * Concomitant use of vigabatrin * All patients diagnosed with congenital short QT syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in total partial seizure frequency from baseline. | 22 weeks |
Countries
United States
Outcome results
None listed